Format for Clinical Data Presentations in Orthopedic Implant Device Submissions
This guidance provides recommended formats for presenting clinical data in premarket notifications (510(k)s), IDE annual progress reports, PMA applications, and annual/post-approval study reports specifically for orthopedic implant devices. It aims to standardize data presentations to facilitate review but does not cover preclinical data presentation requirements.
Recommended Actions
- Develop standardized data collection forms aligned with recommended presentation formats
- Establish clear definitions for subsequent surgical interventions in IDE protocol
- Implement tracking system for patient follow-up to maintain minimum 85% rate
- Create detailed adverse event reporting process including categorization system
- Define success/failure criteria for surgical interventions in study protocol
- Establish process for separate tracking of protocol deviation cases
- Develop templates for demographic data collection aligned with recommended tables
- Create system for tracking effectiveness parameters over time
- Implement process for documenting and categorizing all adverse events
- Establish procedure for narrative documentation of adverse events and surgical interventions
Key Considerations
Clinical testing
- Minimum 85% follow-up rate recommended for each study cohort
- Clear description of evaluation intervals pre/post-treatment with defined follow-up windows
- Patient accounting must track theoretical follow-up, deaths, failures, expected and actual follow-up
- Time course distributions of effectiveness parameters (pain, function, radiographic assessments, etc.)
- Individual patient success rates over time
Safety
- Record and report all preoperative, operative, and postoperative complications
- Categorize adverse events as device-related, operative site-related, and systemic
- Track subsequent secondary surgical interventions (revisions, removals, reoperations, supplemental fixations)
- Provide detailed narratives for adverse events
Other considerations
- Complete description of patient population demographics
- Stratification of data by investigational/control groups and relevant subgroups
- Separate presentations for patients implanted outside study protocol
- Statistical rationale for pooling data from protocol deviations
Relevant Guidances
- Clinical Trial Considerations for Neurological Devices Intended to Slow, Stop, or Reverse Disease Progression
- Benefit-Risk Factors in IDE Applications for Medical Device Clinical Investigations
- IDE Clinical Investigation Decision Process and Requirements
- Design Considerations for Medical Device Pivotal Clinical Studies
Related references and norms
- WHO International Classification Systems: International Classification of Diseases
- WHO International Classification Systems: International Classification of Impairments, Disability and Handicaps
Original guidance
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